Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
Reported: June 17, 2020 Initiated: November 4, 2019 #Z-2301-2020
Product Description
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
Reason for Recall
False positive results due to potential contamination of reagent.
Details
- Recalling Firm
- Immuno-Mycologics, Inc
- Units Affected
- 155 vials
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, MI, MN, NY,TX, UT, VA, WI and the countries of France, Spain, Hong Kong, United Kingdom.
- Location
- Norman, OK
Frequently Asked Questions
What product was recalled? ▼
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen. Recalled by Immuno-Mycologics, Inc. Units affected: 155 vials.
Why was this product recalled? ▼
False positive results due to potential contamination of reagent.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2301-2020.
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